Research and Development Program Manager
Role Overview
Leads cross-functional execution across an existing diagnostic platform and related product initiatives.
Initial priority is engineering work for CE/IVDR readiness; future programs may include fertility tests, sperm testing, saliva-based platforms, or other product priorities.
Works across assay, hardware, software, data, manufacturing, and quality teams using design control and agile execution.
Key Skills for This Role
Full Job Posting
Role overview
Leads cross-functional execution across an existing diagnostic platform and related product initiatives.
Initial priority is engineering work for CE/IVDR readiness; future programs may include fertility tests, sperm testing, saliva-based platforms, or other product priorities.
Works across assay, hardware, software, data, manufacturing, and quality teams using design control and agile execution.
Core responsibilities
- Own design-control execution for product lifecycle work and future regulated product programs, including compliance with ISO 13485 and applicable regulatory requirements.
- Translate market, regulatory, and product needs into requirements and traceable execution plans through verification and validation.
- Coordinate Assay, Reader/Hardware, Software/App, Data Science/AI, Mechanical/Packaging, Manufacturing, and Quality/Regulatory teams.
- Run sprint-based execution while maintaining compliance, agreed delivery dates, program risks, dependencies, and verification/validation needs.
- Track cost, schedule, and risk; identify slippage, establish recovery plans, and escalate unresolved blockers.
- Support analytical performance characterization from R&D through manufacturing scale and ensure software and digital components are tested and documented appropriately.
- Drive manufacturability, reliability, and usability across reader, mechanical, consumable, and packaging development.
- Partner with QA/RA on CE-IVDR and future submissions by ensuring engineering evidence is complete, timely, and defensible.
Candidate profile
- Requires 5+ years managing regulated product development in IVD, medical devices, connected diagnostics, or similarly complex engineering products.
- Requires strong knowledge of design control, risk management, verification/validation, and regulatory readiness; direct IVDR experience is useful but not mandatory.
- Requires technical fluency across relevant domains such as diagnostics/assays, electronics, mechanical systems, software, imaging, or data-driven products.
- Requires experience leading multi-site R&D teams and strong communication and execution discipline.
- Requires the ability to hold technical teams accountable to aggressive timelines, challenge weak commitments, and escalate blockers early.
- Requires comfort in a fast-paced, startup-style environment with minimal hierarchy.
Expected outcomes
Deliver product lifecycle and new-product programs that meet analytical, usability, manufacturing, schedule, and regulatory goals.
Establish predictable cross-functional execution and traceable engineering evidence for audit-ready design files and regulatory dossiers.
Create a reusable program framework for future product improvements and adjacent diagnostic launches.
Apply for this job in 1 click
Skip the repetitive application forms
Install the Base Career Chrome Extension and autofill job applications across major job boards with your profile.
Trusted by over 500,000 job seekers on Base Career
More from this employer
More jobs at JBAndrews
Quality Control Manager - Assays
, UAE
Inito is seeking a Quality Control Manager to own assay-critical quality systems across raw materials, intermediates, assembled strips, and finished diagnostic products. The role covers QC strategy, method validation, su
Principal Consultant
, UAE
JBAndrews is seeking an experienced Principal Consultant for its Dubai executive search teams serving logistics and supply chain, medical and life science, or industrial markets. The role combines client development, exe